Event Text Entries

[187177928]
(b)(4). Patient Sequence No: 1, Text Type: N, H10

[187177929]
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred. The sensor was inserted into the abdomen on (b)(6) 2020. Data was evaluated and the allegation was undetermined. The probable cause could not be determined via data. The reported glucose values fall within the? D zone of the parkes error grid. The data investigation did not find blood glucose calibration values to compare to cgm values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications. No injury or medical intervention was reported. Patient Sequence No: 1, Text Type: D, B5